Mindfulness-Based Cognitive Therapy Delivered Via Group Videoconferencing for Acute Coronary Syndrome Patients With Depressive Symptoms
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Recruitment Feasibility: Percent of Participants Who Consent to Screening
研究概览
简要总结
Brief Summary: The aim of this study is to explore the initial feasibility and acceptability of (a) Mindfulness-Based Cognitive Therapy (MBCT) adapted for ACS patients; (b) the group videoconferencing delivery medium; and (c) dried blood spot research procedures, to inform refinements for a subsequent pilot RCT.
详细描述
The current study will employ an open pilot trial to determine the initial feasibility and acceptability of a targeted, virtual MBCT intervention for ACS patients. The investigators plan to enroll approximately N=20 patients (2 cohorts of 10 participants/per cohort, accounting for 20% anticipated lost to follow-up). The MBCT intervention will involve 8 virtually-delivered MBCT sessions (approximately 1.5 hours each), during which participants will be taught how to use evidence-based mindfulness skills to regulate distress and choose healthy behaviors, as well as learn about cardiac health. Participants will be asked to complete a brief survey following each session. Within one week before and after the intervention and 3-months post-intervention participants will be asked to complete a series of questionnaires and provide self-collected blood samples. Upon completion of the intervention participants will complete an audio-or video recorded exit interview (approximately 30 minutes).
Participants will be recruited through the the hospital's clinical data registry, advertisements (e.g., flyers, brochures) placed throughout the hospital, direct provider referrals, and from inpatient cardiac units. Patients who express interest in the study will be asked complete an eligibility screening. Eligible patients agreeable with study participation will then complete a written consent with study staff prior to enrollment.
Participants will be enrolled in one of two MBCT intervention cohorts and expected to participate in 8-weekly, 1.5-hour virtual sessions, in conjunction with approximately 30 minutes of at-home daily practice. A licensed mental health provider (e.g., LICSW, PhD) trained in the MBCT protocol will deliver the intervention. The MBCT intervention will be delivered Zoom, a secure, HIPPA-compliant video-conferencing software.
Study assessments will include a battery of self-report surveys administered at baseline, post-intervention, and 3-month follow-up; session satisfaction surveys administered after each intervention session; post-intervention individual exit interviews (conducted via telephone or videoconference); blood spot samples self-collected by participants at baseline, post-intervention, and 3-month follow-up (submitted to the research team via paper mail); and home practice logs submitted between each intervention session. Primary outcomes for the intervention are feasibility and acceptability. Data collected from the study will be used to assist in the development of future RCTs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Lifetime ACS per medical record and/or patient confirmation
- •Current elevated depression symptoms (PHQ-9>5)
- •Age 35-85 years
- •Access to high-speed internet
排除标准
- •Active suicidal ideation or past-year psychiatric hospitalization (per patient report and/or medical record review)
- •Non-English-speaking
- •Cognitive impairments preventing informed consent per medical record review and/or cognitive Screen < 4
- •Patient deemed unable to complete the study protocol or has a condition that would likely interfere with the study
结局指标
主要结局
Recruitment Feasibility: Percent of Participants Who Consent to Screening
时间窗: 6 months
Feasibility outcomes for recruitment will include: \>70% of patients reached consent to screening
Recruitment Feasibility: Percent of Participants Meeting Screening Criteria
时间窗: 6 months
Feasibility outcomes for recruitment will include: \>70% meet screening criteria
MBCT Feasibility: Percent of Participants Adherent to the MBCT Intervention
时间窗: 6 Months
MBCT feasibility will be measured by: \>75% session attendance (i.e., percent who attend at least 6/8 intervention sessions)
Videoconferencing Feasibility: Percent of Connections Dropped During Sessions
时间窗: 6 Months
Videoconferencing feasibility will be assessed by: \< 20% of connections dropped during session
Blood Spot Feasibility: Percent of Participants Submitting Blood Spot Samples at Follow-up
时间窗: 6 Months
Blood spot feasibility will be assessed by: \>60% of participants submitting samples at follow-up
Blood Spot Feasibility: Percent of Adequate Blood Spot Samples Submitted
时间窗: 6 Months
Blood spot feasibility will be assessed by: 80% of samples of adequate quality for processing.
Recruitment Feasibility: Percent of Eligible Patients Who Consent
时间窗: 6 Months
Feasibility outcomes for recruitment will include: \>70% of eligible consent to the study
MBCT Feasibility: Percent of Participants Retained at Post-Intervention
时间窗: 3 Months
MBCT feasibility will be measured by: \>75% post-intervention assessments completed
Blood Spot Feasibility: Percent of Participants Submitting Blood Spot Sample at Post-Intervention
时间窗: 6 Month
Blood spot feasibility will be assessed by: \>75% of participants submitting samples at post-intervention
MBCT Acceptability: Usefulness of Session Components
时间窗: 6 months
The average usefulness ratings for session components on a scale of 1 = not at all useful to 10 = very useful, with mean \>= 7.5 being considered acceptable
Videoconferencing Acceptability: Ratings of Videoconferencing Ease of Use
时间窗: 6 Months
Videoconferencing acceptability will be assessed in terms of ease of use (1= very much, 10 = not at all; M \>= 7.5)
Blood Spot Feasibility: Percent of Participants Submitting Blood Spot Samples at Baseline
时间窗: 6 months
Blood spot feasibility will be assessed by: \>75% of participants submitting samples at baseline
Videoconferencing Acceptability: Ratings of Videoconferencing Quality Surveys)
时间窗: 6 Months
Videoconferencing acceptability will be assessed in terms of video quality of mindfulness videoconference sessions (1= Very Poor to 10 = Very Good, M\>7.5)
Videoconferencing Acceptability: Ratings of Videoconferencing Satisfaction
时间窗: 6 Months
Videoconferencing acceptability will be assessed in overall satisfaction of use (1 = not at all satisfied to 10 = very satisfied, M \> 7.5)
MBCT Acceptability: Helpfulness for Mood
时间窗: 6 months
Ratings of how helpful the MBCT sessions were for improving mood (1 = not at all helpful to 10 = very helpful), with acceptability defined as Mean \>= 7.5
Blood Spot Acceptability: Ease of Blood Spot Collection
时间窗: Average rating for ease of data submission from blood spot collection through out all groups
Blood spot acceptability will be assessed by ratings of ease of blood spot collection (1 = not at all, 10 = very easy; M\>7.5)
Blood Spot Acceptability: Discomfort of Blood Spot Collection
时间窗: 6 Months
Blood spot acceptability will be assessed by ratings of level of pain during blood spot collection, (1=Very much pain, 10=Very little pain; M\>=7.5).
次要结局
- Patient Health Questionnaire (PHQ-9)(6 months)
研究者
Christina Luberto
Principal Investigator
Massachusetts General Hospital